510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844110Substantially Equivalent

Xtraceteze Surgical Skin Staple Remover 2001

Pelco, Inc., Annapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844110 is the FDA 510(k) clearance record for XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001, a class I device, cleared for Pelco, Inc. on under FDA product code PYE (Staple Removal Kit). FDA's definition for product code PYE reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at...". FDA records list one 510(k) clearance for Pelco, Inc. As of , FDA records show no recalls naming K844110.

Clearance record

Decision date
Received
(27 days to decision)
Product code
PYE Staple Removal Kit
Regulation
21 CFR 878.4760
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pelco, Inc. 1040 Harbor Dr., Annapolis MD
Third party review
No

Clearances, product code PYE

Trailing 12 months

FDA records hold no clearances under product code PYE in the trailing twelve months.

FDA records show no clearances under product code PYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260